坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数2000
标示量(mg)6.25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.012334022328542329302329882328452330040.10
212.012334402334762334580.02
单位质量响应值RSD%判断
19400.8319438.630.14数据可信
稳定性12月-中间条件-供试品溶液-2023020821批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1136961-13696150.62747.594.4250.6347.594.42
2122309-12230945.21145.21
3127701-12770147.20447.20
4133513-13351349.35249.35
5123366-12336645.60245.60
6128618-12861847.54347.54
10min1251247-25124792.87290.572.0592.9690.652.05
2242456-24245689.62389.70
3247819-24781991.60591.68
4240625-24062588.94689.03
5238904-23890488.31088.39
6249019-24901992.04992.13
15min1270534-270534100.00298.411.03100.2498.641.03
2264331-26433197.70997.93
3263279-26327997.32097.55
4268493-26849399.24799.48
5265510-26551098.14498.37
6265270-26527098.05698.29
20min1271190-271190100.24498.751.04100.6599.141.04
2265200-26520098.03098.42
3264139-26413997.63898.03
4269818-26981899.737100.13
5266132-26613298.37498.76
6266342-26634298.45298.85
30min1271109-271109100.21498.721.11100.7999.281.11
2265253-26525398.04998.60
3263432-26343297.37697.93
4270084-27008499.835100.40
5266335-26633598.44999.00
6266198-26619898.39998.96
45min1270197-27019799.87798.621.02100.6299.351.02
2265627-26562798.18898.90
3263411-26341197.36998.09
4269944-26994499.783100.51
5266370-26637098.46299.18
6265278-26527898.05998.78
60min1269732-26973299.70598.431.01100.6199.321.02
2264849-26484997.90098.78
3262872-26287297.16998.05
4269321-26932199.553100.45
5265701-26570198.21599.09
6265298-26529898.06698.95
极限1269685-26968599.68898.461.02100.7699.521.02
2265445-26544598.12099.16
3262777-26277797.13498.18
4269522-26952299.627100.69
5265551-26555198.16099.20
6265277-26527798.05899.11
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.901502611497551499531501211499331500050.13
215.931506501506081506290.02
单位质量响应值RSD%判断
9434.289455.680.17数据可信
稳定性12月-中间条件-供试品溶液-2023020821批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141834-4183424.86523.473.4124.8623.473.40
238661-3866122.97922.98
339638-3963823.55923.56
440066-4006623.81423.81
538272-3827222.74822.75
638471-3847122.86622.87
10min196622-9662257.42955.761.8057.4755.801.81
293224-9322455.40955.45
394667-9466756.26756.31
493562-9356255.61055.65
591632-9163254.46354.50
693147-9314755.36355.40
15min1126277-12627775.05573.541.1775.1973.671.17
2123434-12343473.36573.50
3122571-12257172.85272.98
4124514-12451474.00774.14
5122688-12268872.92173.05
6122854-12285473.02073.15
20min1140123-14012383.28481.611.1683.5581.861.16
2136625-13662581.20581.46
3136108-13610880.89881.15
4138275-13827582.18682.44
5136324-13632481.02681.28
6136370-13637081.05381.31
30min1152353-15235390.55389.281.0290.9589.671.02
2149324-14932488.75389.14
3148289-14828988.13888.53
4151670-15167090.14790.54
5149991-14999189.14989.53
6149657-14965788.95189.34
45min1159473-15947394.78593.471.2095.3494.011.20
2156082-15608292.77093.31
3154898-15489892.06692.60
4159328-15932894.69995.24
5157696-15769693.72994.26
6156083-15608392.77093.31
60min1161618-16161896.06094.871.1496.7795.571.14
2158183-15818394.01894.71
3157213-15721393.44294.13
4161560-16156096.02596.73
5160222-16022295.23095.92
6158919-15891994.45695.15
极限1162439-16243996.54895.421.1297.4296.281.12
2159211-15921194.62995.48
3158178-15817894.01594.86
4162679-16267996.69197.55
5160895-16089595.63096.48
6159866-15986695.01995.87
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数2000
标示量(mg)6.25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.012344522346162347262347242343412345720.08
212.012334702334772334740.01
单位质量响应值RSD%判断
19531.3919439.970.34数据可信
稳定性12月-中间条件-供试品溶液-2023020921批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1135915-13591550.07043.8218.0350.0743.8218.03
2135968-13596850.09050.09
3132805-13280548.92548.92
4121953-12195344.92744.93
582928-8292830.55030.55
6104084-10408438.34438.34
10min1256472-25647294.48389.279.2294.5789.349.23
2259796-25979695.70895.79
3262095-26209596.55596.64
4242909-24290989.48789.56
5205232-20523275.60775.66
6227413-22741383.77883.84
15min1272294-272294100.31298.671.38100.5598.891.39
2265679-26567997.87598.12
3272457-272457100.372100.61
4263831-26383197.19497.42
5265517-26551797.81597.99
6267225-26722598.44598.65
20min1272678-272678100.45399.031.25100.8699.421.25
2265953-26595397.97698.38
3273066-273066100.596101.01
4265195-26519597.69798.08
5268197-26819798.80399.14
6267857-26785798.67799.04
30min1273520-273520100.76499.441.18101.3499.991.18
2267170-26717098.42498.99
3273838-273838100.881101.46
4266287-26628798.09998.65
5269670-26967099.34599.85
6269064-26906499.12299.65
45min1273443-273443100.73599.321.23101.48100.041.24
2266754-26675498.27199.00
3273657-273657100.814101.56
4265811-26581197.92498.64
5268672-26867298.97899.65
6269292-26929299.20699.90
60min1273278-273278100.67499.241.18101.59100.131.19
2266440-26644098.15599.05
3273171-273171100.635101.55
4266115-26611598.03698.91
5268597-26859798.95099.79
6268776-26877699.01699.88
极限1273271-273271100.67298.991.25101.75100.041.26
2265599-26559997.84698.91
3272321-272321100.322101.40
4265353-26535397.75598.79
5268101-26810198.76799.77
6267633-26763398.59599.62
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.901511081512121513621510781506711510860.18
215.931508291508901508600.03
单位质量响应值RSD%判断
9502.269470.180.24数据可信
稳定性12月-中间条件-供试品溶液-2023020921批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138513-3851322.79120.0617.6822.7920.0617.68
238903-3890323.02223.02
337897-3789722.42722.43
434838-3483820.61620.62
524399-2439914.43914.44
628795-2879517.04017.04
10min193353-9335355.24551.5510.8255.2851.5910.82
295189-9518956.33156.37
394546-9454655.95155.99
487320-8732051.67451.71
571476-7147642.29842.32
680804-8080447.81847.85
15min1122952-12295272.76170.493.9272.8970.613.93
2122001-12200172.19872.33
3123852-12385273.29373.42
4117911-11791169.77769.90
5111875-11187566.20566.30
6116084-11608468.69668.80
20min1137349-13734981.28179.302.2281.5379.532.24
2135007-13500779.89580.15
3137187-13718781.18581.44
4132268-13226878.27478.51
5130160-13016077.02677.23
6132007-13200778.11978.34
30min1151180-15118089.46588.011.4389.8588.381.44
2148318-14831887.77288.16
3151423-15142389.60990.00
4146202-14620286.52086.89
5147365-14736587.20887.54
6147821-14782187.47887.83
45min1158555-15855593.83092.601.3694.3793.121.37
2155044-15504491.75292.28
3159359-15935994.30694.84
4153787-15378791.00891.52
5155662-15566292.11892.60
6156451-15645192.58593.08
60min1161307-16130795.45894.201.3396.1594.871.33
2157563-15756393.24393.93
3161926-16192695.82596.52
4156496-15649692.61193.27
5158592-15859293.85294.48
6159187-15918794.20494.86
极限1162028-16202895.88594.621.2496.7495.451.24
2158466-15846693.77794.62
3162309-16230996.05196.91
4157346-15734693.11493.93
5159959-15995994.66195.45
6159238-15923894.23495.04
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数2000
标示量(mg)6.25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.012357182361502363682366732368282363470.19
212.012320752320432320590.01
单位质量响应值RSD%判断
19679.1819322.151.30数据可信
稳定性12月-中间条件-供试品溶液-2023021021批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1145358-14535853.51249.0814.7953.5149.0714.79
2125452-12545246.18446.18
398797-9879736.37136.37
4132541-13254148.79448.79
5154326-15432656.81456.81
6143379-14337952.78452.78
10min1270083-27008399.42997.172.4899.5297.252.48
2255239-25523993.96494.04
3260170-26017095.77995.84
4259457-25945795.51795.60
5271076-27107699.79499.89
6267671-26767198.54198.63
15min1278229-278229102.428102.481.02102.68102.721.02
2277250-277250102.067102.30
3279583-279583102.926103.15
4275834-275834101.546101.79
5283354-283354104.314104.58
6275937-275937101.584101.84
20min1278714-278714102.606102.621.00103.03103.031.00
2278415-278415102.496102.90
3280097-280097103.115103.51
4276501-276501101.791102.20
5283292-283292104.292104.73
6275450-275450101.405101.83
30min1277725-277725102.242102.470.98102.84103.060.98
2277872-277872102.296102.87
3279844-279844103.022103.59
4276147-276147101.661102.24
5282979-282979104.176104.78
6275559-275559101.445102.04
45min1277697-277697102.232102.510.95103.00103.260.95
2277791-277791102.266103.01
3280234-280234103.166103.90
4276635-276635101.841102.59
5282786-282786104.105104.89
6275559-275559101.445102.20
60min1277442-277442102.138102.251.01103.08103.181.01
2277394-277394102.120103.04
3279335-279335102.835103.74
4276254-276254101.701102.62
5282163-282163103.876104.83
6273899-273899100.834101.76
极限1277624-277624102.205102.231.01103.31103.321.01
2277646-277646102.213103.30
3279960-279960103.065104.14
4275945-275945101.587102.67
5281388-281388103.591104.72
6273552-273552100.706101.80
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.901532061534361534541535391530801533430.13
215.931505981503591504780.12
单位质量响应值RSD%判断
9644.219446.201.47数据可信
稳定性12月-中间条件-供试品溶液-2023021021批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140181-4018123.63422.0315.0023.6322.0314.99
236263-3626321.32921.33
326927-2692715.83815.84
438413-3841322.59422.59
543013-4301325.30025.30
639948-3994823.49723.50
10min198496-9849657.93456.134.8357.9756.164.83
293169-9316954.80154.84
387808-8780851.64751.67
494800-9480055.76055.80
5100771-10077159.27259.31
697505-9750557.35157.39
15min1126701-12670174.52474.191.7174.6674.321.72
2125055-12505573.55673.68
3123683-12368372.74972.86
4125121-12512173.59473.72
5129954-12995476.43776.58
6126250-12625074.25874.39
20min1140942-14094282.90082.870.9983.1683.120.99
2140881-14088182.86483.11
3140174-14017482.44882.68
4139507-13950782.05682.31
5143499-14349984.40484.67
6140321-14032182.53582.79
30min1154456-15445690.84991.111.0091.2591.511.00
2154960-15496091.14591.53
3155621-15562191.53491.91
4152855-15285589.90790.30
5157443-15744392.60693.01
6154111-15411190.64691.04
45min1162129-16212995.36295.881.1395.9196.421.13
2163300-16330096.05196.59
3164242-16424296.60597.13
4160679-16067994.50995.05
5165813-16581397.52998.09
6161883-16188395.21795.76
60min1164940-16494097.01597.291.1697.7298.001.16
2165782-16578297.51198.21
3166842-16684298.13498.82
4163222-16322296.00596.70
5168154-16815498.90699.63
6163538-16353896.19196.90
极限1166161-16616197.73497.781.2998.6098.651.28
2166825-16682598.12498.99
3167847-16784798.72599.57
4164287-16428796.63197.49
5169013-16901399.411100.30
6163331-16333196.06996.94
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